Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA has granted traditional approval to tisotumab vedotin-tftv (Tivdak, Seagen [now part of Pfizer]) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for this indication.
Efficacy was evaluated in innovaTV 301 (ClinicalTrials.gov. Identifier NCT04697628), a multicenter, open-label, active-controlled randomized trial that enrolled 502 patients with recurrent or metastatic cervical cancer who had received one or two prior systemic regimens, including chemotherapy with or without bevacizumab and/or an anti-PD-(L)-1 (programmed death-ligand 1) agent. Patients were excluded if they had active ocular surface disease, any prior episode of cicatricial conjunctivitis or ocular Stevens-Johnson syndrome, grade 2 or higher peripheral neuropathy, or clinically significant bleeding issues or risks.
Patients were randomized (1:1) to receive either tisotumab vedotin 2 mg/kg intravenously every three weeks or investigator’s choice of chemotherapy consisting of topotecan, vinorelbine, gemcitabine, irinotecan or pemetrexed, until unacceptable toxicity or disease progression.
The major efficacy outcome measure was overall survival (OS). Additional efficacy outcome measures were progression-free survival (PFS) and confirmed objective response rate (ORR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors, version 1.1. Median OS was 11.5 months (95% CI, 9.8-14.9 months) in the tisotumab vedotin arm and 9.5 months (95% CI, 7.9-10.7 months) in the chemotherapy arm (hazard ratio [HR], 0.70; 95% CI, 0.54-0.89; P=0.0038). Median PFS was 4.2 months (95% CI, 4.0-4.4 months) in the tisotumab vedotin arm and 2.9 months (95% CI, 2.6-3.1 months) for those treated with chemotherapy (HR, 0.67; 95% CI, 0.54-0.82; P<0.0001). Confirmed ORR was 17.8% (95% CI, 13.3%-23.1%) and 5.2% (95% CI, 2.8%-8.8%) in the respective arms (P<0.0001). This trial’s results fulfilled the post-marketing requirement of the previous accelerated approval.
The most common adverse reactions (≥25%), including laboratory abnormalities, were decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, fatigue, decreased sodium, epistaxis and constipation.
Full prescribing information for Tivdak will be posted here.
Based on a press release from the FDA.
